A comprehensive post-hoc analysis of six phase 3 and 4 clinical trials has revealed that prucalopride (Motegrity) maintains its efficacy in treating chronic idiopathic constipation (CIC) across various patient demographics, with some notable variations based on specific patient characteristics.
Efficacy Across Age Groups
The analysis, led by Dr. Anthony Lembo, Director of Research at the Cleveland Clinic's Digestive Disease Institute, evaluated prucalopride's performance in different age cohorts. The study demonstrated significant improvements in complete spontaneous bowel movements (CSBMs) across all age groups, including patients under 50, 50-64 years, and those 65 years and older.
Impact of BMI and Renal Function
The research revealed interesting patterns in treatment response based on patient BMI and renal function. Among patients with underweight or healthy BMI (< 25 kg/m²), 24.8% achieved the primary endpoint of at least three CSBMs weekly, compared to 10.9% in the placebo group (P < .001). Similarly, overweight patients showed significant improvement (34.6% vs. 15.4%, P < .001).
However, the drug's efficacy showed some limitations in specific patient populations. Patients with obesity did not achieve statistically significant improvements (25.1% vs. 19.1%). Similarly, while patients with normal renal function (29.8% vs. 13.7%, P < .001) and mild renal impairment (26.2% vs. 12.8%, P < .001) showed marked improvement, those with moderate renal impairment demonstrated more modest benefits that did not reach statistical significance (17.7% vs. 12.2%).
Study Design and Patient Population
The analysis included a substantial patient cohort, with 2,484 patients stratified by age (1,237 receiving prucalopride, 1,247 placebo), 2,482 by BMI, and 2,474 by renal function. The treatment protocol involved daily doses of either 1 mg or 2 mg of prucalopride over a 12-week period.
Safety Profile
While the treatment group reported more adverse events compared to placebo, researchers noted that no unexpected safety concerns emerged during the study. This finding reinforces prucalopride's established safety profile across different patient populations.
Clinical Implications
These findings provide valuable insights for healthcare professionals in tailoring treatment approaches. Dr. Lembo and colleagues noted that while prucalopride demonstrates broad efficacy, there are "slight differences in the efficacy profile" based on BMI and renal function, suggesting the importance of considering these factors in treatment decisions.
The research builds on previous pharmacokinetic analyses showing no clinically significant differences in prucalopride's profile based on age (17-95 years) or BMI (14-57 kg/m²) after accounting for renal function effects. This new analysis adds important clinical outcome data to support these pharmacokinetic findings.
